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Cysteamine bitartrate - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for cysteamine bitartrate?

Cysteamine bitartrate is the generic ingredient in two branded drugs marketed by Raptor Inc and Mylan, and is included in two NDAs. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has thirty-two patent family members in twenty-five countries.

There are five drug master file entries for cysteamine bitartrate. Two suppliers are listed for this compound.

Summary for Generic Name: cysteamine bitartrate

Tradenames:2
Patents:6
Applicants:2
NDAs:2
Drug Master File Entries: see list5
Suppliers / Packagers: see list2
Bulk Api Vendors: see list14
Clinical Trials: see list22
Patent Applications: see list60
Therapeutic Class:Enzyme Replacements/Modifiers
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:cysteamine bitartrate at DailyMed

Pharmacology for Ingredient: cysteamine bitartrate

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Raptor Inc
PROCYSBI
cysteamine bitartrate
CAPSULE, DELAYED RELEASE;ORAL203389-001Apr 30, 2013RXYesNo► Subscribe► Subscribe
Mylan
CYSTAGON
cysteamine bitartrate
CAPSULE;ORAL020392-002Aug 15, 1994RXYesYes► Subscribe► Subscribe
Raptor Inc
PROCYSBI
cysteamine bitartrate
CAPSULE, DELAYED RELEASE;ORAL203389-002Apr 30, 2013RXYesYes► Subscribe► Subscribe
Raptor Inc
PROCYSBI
cysteamine bitartrate
CAPSULE, DELAYED RELEASE;ORAL203389-002Apr 30, 2013RXYesYes9,173,851► SubscribeY ► Subscribe
Raptor Inc
PROCYSBI
cysteamine bitartrate
CAPSULE, DELAYED RELEASE;ORAL203389-001Apr 30, 2013RXYesNo9,173,851► SubscribeY ► Subscribe
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Non-Orange Book Patents for Generic Ingredient: cysteamine bitartrate

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,129,433Enterically coated cysteamine, cystamine and derivatives thereof► Subscribe
9,511,039Enterically coated cysteamine, cystamine and derivatives thereof► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: cysteamine bitartrate

Country Document Number Estimated Expiration
Denmark1919458► Subscribe
Israel193044► Subscribe
Canada2938644► Subscribe
Australia2014281702► Subscribe
Taiwan201534357► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: CYSTEAMINE BITARTRATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
/2014Austria► SubscribePRODUCT NAME: CYSTEAMIN; REGISTRATION NO/DATE: EU/1/13/861/001-002 20130910
4 50001-2014Slovakia► SubscribePRODUCT NAME: MERKAPTAMIN; REGISTRATION NO/DATE: EU/1/13/861 20130906
00649Netherlands► SubscribePRODUCT NAME: CYSTEAMINE; REGISTRATION NO/DATE: EU/1/13/861/001-002 20130906
0649Netherlands► SubscribePRODUCT NAME: CYSTEAMINE; REGISTRATION NO/DATE: EU/1/13/861/001-002 20130910
2014 00013Denmark► SubscribePRODUCT NAME: CYSTEAMIN, HERUNDER MERCAPTAMINBITARTRAT; REG. NO/DATE: EU/1/13/861 20130906
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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